FDAHealthOctober 8, 2025
Olympus Corporation of the Americas — Brand Name: Lithotriptor, Ultrasonic Product Name: ShockPulse Lithotripsy Transducer Model/Catalog Number: SPL-T Product Description: The ShockPulse Lithotrips
⚠️ The device may either fail to start up, or the transducer may start briefly and then stop, accompanied by an error light on the generator. In addition, the body of the transducer handpiece may gradually increase in temperature during clinical use.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- October 8, 2025
Worldwide distribution - US Nationwide and the countries of Canada, India, Taiwan, Germany, Australia, Singapore.
What's affected?
- Product
- Brand Name: Lithotriptor, Ultrasonic Product Name: ShockPulse Lithotripsy Transducer Model/Catalog Number: SPL-T Product Description: The ShockPulse Lithotripsy System is an electromechanical device capable of fragmenting calculi and aspirating stone debris. The ShockPulse transducer is a reusable device that requires cleaning and steam sterilization prior to use in order to generate both low-frequency mechanical impacts and high-frequency ultrasonic energy that quickly disintegrates stones. Component: ShockPulse Lithotripsy System
- Lot code
- Model/Catalog Number: SPL-T; UDI-PI: 00855279005023; All serial numbers;
Additional details
Model/Catalog Number: SPL-T; UDI-PI: 00855279005023; All serial numbers;
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 1528 units.
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